MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC SYMMETRY RAPIDCLEAN; KERRISON RONGEUR

Catalog Number	58-3200J-BD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw was returned with the product.Upon evaluating, it was noted that the screw had damage that was consistent with tampering with the screw in some way.This customer has had multiple recent complaints for the screws becoming loose.It can be determined that there is a specific problem going on in the sterile processing department.There has been a total 328 sold of all lots with 4 total complaints recorded for similar occurrences.Of the four complaints, 2 were received by this customer.The other two complaints were from (b)(6) 2019 and 2015 and were both found to have damage to the screws as well.As a courtesy, we are letting the customer send in their remaining sets to repaired by our contract repair facility and the screws reset.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The screw fell out of the 3mm kerrison and fell into the spinal erea.It took some time to find the screw, but it was removed with no further harm to the patient.

• Brand Name: SYMMETRY RAPIDCLEAN
• Common Device Name: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch, tn
• MDR Report Key: 10512221
• Report Number: 3007208013-2020-00024
• Device Sequence Number: 2940621
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 58-3200J-BD
• Device Lot Number: T01-81802648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1